A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity
Purpose
The main purpose of this study is to learn more about the safety and efficacy of investigational tirzepatide doses in participants with Type 2 diabetes and obesity that are already taking metformin. The study will last for about 89 weeks.
Conditions
- Type 2 Diabetes
- Obesity
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Have a Body Mass Index (BMI) ≥35 kilogram/square meter (kg/m²) at screening. - Have had stable body weight (±5%) during the 90 days preceding screening. - Have been diagnosed with Type 2 Diabetes (T2D). - Have been on a stable treatment of metformin only at least 90 days preceding screening and between screening and randomization with the minimum effective dose of ≥1500 milligram (mg)/day.
Exclusion Criteria
- Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D. - Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 6 months prior to screening. - Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema. - Have a prior or planned surgical treatment for obesity. - Use products intended for weight loss including prescription drugs, over the counter (OTC) drugs, and herbal preparations, within 3 months prior to screening. - Have renal impairment measured as estimated glomerular filtration rate (eGFR) <45 milliliter/min (mL/min)/1.73 m². - Have any of the following cardiovascular (CV) conditions within 2 months prior to screening. - acute myocardial infarction. - cerebrovascular accident (stroke). - unstable angina . - hospitalization due to congestive heart failure, or - coronary artery revascularization. - Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2. - Have a history of chronic or acute pancreatitis.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Tirzepatide High Dose 1 |
Participants will receive tirzepatide subcutaneously (SC). |
|
|
Experimental Tirzepatide High Dose 2 |
Participants will receive tirzepatide SC. |
|
|
Active Comparator Tirzepatide |
Participants will receive tirzepatide SC. |
|
|
Placebo Comparator Placebo |
Participants will receive placebo. |
|
Recruiting Locations
More Details
- NCT ID
- NCT06037252
- Status
- Active, not recruiting
- Sponsor
- Eli Lilly and Company
Detailed Description
The study will include a screening period of up to 5 weeks. The primary endpoint will be at Week 44 with a tirzepatide extension until week 80. A safety follow up will be performed approximately 4 weeks after end of treatment.